Corcept Therapeutics announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for its selective cortisol modulator, relacorilant, to treat patients with platinum-resistant ovarian cancer. This marks the company's second NDA currently under review by the FDA, highlighting its expanding pipeline.
The filing is based on positive data from the pivotal Phase 3 ROSELLA trial and earlier Phase 2 trials, which demonstrated improved progression-free and overall survival for patients receiving relacorilant plus nab-paclitaxel. Importantly, these benefits were observed without the need for biomarker selection and without increasing the safety burden compared to nab-paclitaxel monotherapy.
This submission represents a significant step towards addressing a high unmet medical need in platinum-resistant ovarian cancer, a condition with few effective treatment options. Corcept's oncology and endocrinology business units are preparing to ensure relacorilant's availability immediately following potential regulatory approval, aiming to establish it as a new standard of care.
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